EMCrit Wee – Sean Townsend of the SSC and the ProCESS Trial

Recently, I got to talk to Sean Townsend, MD; a critical care doc and a member of the Surviving Sepsis Campaign (SSC) steering committee. The spark for this conversation was the recent SSC response to the ProCESS trial (read below) as well as the elimination of CVP and ScvO2 from the National Quality Forum (NQF) sepsis bundle.

Surviving Sepsis Campaign Responds to ProCESS Trial

The Surviving Sepsis Campaign (SSC) has received many inquiries regarding the recent publication of the Protocol-Based Care for Early Septic Shock (ProCESS) trial’s effect on the continuing activities of the Campaign.

The ProCESS trial reflects the consensus that early diagnosis of septic shock is essential. Notably, all groups in the study received on average more than 2 liters of fluid prior to randomization and more than 75% received antibiotics prior to randomization–both elements of the 3-hour Surviving Sepsis Campaign bundle. (2) The editorial accompanying the ProCESS study highlights these points. (3)

The 18% mortality rate in the “usual care” arm of ProCESS illustrates a dramatic change in the management and outcomes of patients with septic shock. (1) In comparison, septic shock mortality was 46.5% in the 2001 early goal-directed therapy trial by Rivers. (4) Given that 70% of the hospitals in ProCESS had some form of “sepsis protocol,” we believe this mortality rate demonstrates the success of the SSC in increasing awareness and attention to the challenge of early identification and management of these vulnerable patients.

Given the remarkably low mortality rate in the control arm of ProCESS, the existence of sepsis protocols in the majority of participating study institutions, and the pending results of 2 large ongoing trials (the Australian Resuscitation In Sepsis Evaluation Randomised Controlled Trial [ARISE] and The Protocolised Management in Sepsis Trial [ProMISe]), the SSC has no plans to revise the bundles or National Quality Forum (NQF)-endorsed measures at this time.

ProCESS does not address the protocolized management of patients with severe sepsis without septic shock, a group of patients for whom early detection and treatment remain critical. The aggressive protocolized management of these patients who do not yet have shock has likely lowered severe sepsis and septic shock mortality since the inception of the SSC. The recently formed Society of Critical Care Medicine/Society of Hospital Medicine (SCCM/SHM) Early Diagnosis and Treatment of Severe Sepsis on the Hospital Floors Collaboratives will focus in large part on this population. Further, the ProCESS results have no impact on the 3-hour bundle, which is the primary focus for the Collaboratives.

Regarding the SSC 6-hour bundle:

A companion paper appears to support a mean arterial pressure (MAP) target of 65 mm Hg, which is one of the indicators in this bundle. (5)

The ProCESS paper does not address repeating lactate measures in patients with elevated lactate while literature supports doing so. (6,7)

The majority of the patients in the usual care (56.5%) and protocol-based standard care arms (57.9%) of ProCESS had central lines inserted as part of clinical care. (1) The 6-hour bundle asks only that central venous pressure (CVP) be measured and that a venous blood gas be sent from that line to obtain the central venous oxygen saturation (ScvO2). The ProCESS manuscript does not state how the CVP line was used in the usual care arm nor in the protocol-based standard therapy arm. Similarly, the NQF-endorsed measures of SSC do not set targets for these variables so credit is given for simple collection of the results. (8)

The Surviving Sepsis Campaign looks forward to additional evidence regarding the optimal resuscitation of patients with severe sepsis and septic shock. Given the existing evidence supporting early targeted resuscitation in these patients, SSC continues to recommend all elements of the current bundles.

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Cite this post as:

Scott Weingart. EMCrit Wee – Sean Townsend of the SSC and the ProCESS Trial. EMCrit Blog. Published on May 9, 2014. Accessed on December 10th 2016. Available at [http://emcrit.org/wee/ssc-process-trial-response/ ].

Discussion

Your thoughts:
Patient with SIRS who is normotensive and has a normal lactate. If the labs come back later with criteria for severe sepsis (ie worsening creatinine, bilirubin, low platelets), do you still give this patient 30cc/kg of fluids. Once again the patient has a normal MAP and a normal lactate????

Hi Scott
Really fascinating interview! Clearly there is a bit of beard-stroking to be done by the folk who write the Surviving Sepsis guidelines. Will be interesting to see what happens once PROMISE and ARISE are out there.

As you know – I am a small ED doc and I believe that the ProCESS does change my practice – or at least it means that I can feel more comfortable with my own local pragmatic protocol.

At the end of the day the EGDT protocol is beyond the reach of the majority of non-academic EDs in Australia, and elsewhere. So we need something that is affordable and achievable. In reality most places I see are still providing ad hoc care – which is highly dependent on the individual physician.

The ProCESS new “Standard Protocol” appears to be a winner for the small ED. Largely nurse-driven and requiring no complex calculations or fancy devices. That is a solid formula for great care.

Your SMACC lecture (The first 15000 patients) was awesome – I found it refreshing to hear real-world, practical tips from a data set that represents the average ED, rather than a well resourced, tertiary teaching unit.

Scott–thanks for this wee. It’s nice to be reminded that, though we may quibble with some of the specifics (and I do), these guidelines are put together by smart, thoughtful people that are also looking at the data.

Two comments from your podcast were interesting:
Weingert (about 10:10): “…if you just initiate any protocol that involves caring about these patients you would probably achieve similar reductions in mortality.”
Townsend (about 10:45): “…I believe that protocolized care…will lower mortality versus just doing whatever happens next in the hospital in a random sort of fashion.”
We have very few protocols my current ICU. I told one of the attendings recently we would provide better care if we would just create some protocols that standardized care, even if there was no evidence supporting the choice. For example it is pretty clear patients should be ventilated with lower tidal volumes but as of now there is no evidence to support one mode vs another. I was arguing every patient should be started on the same ventilator mode. Yes, I agree it will not work for everyone but it will work for most, and importantly it will identify those patients who are “special” and need more attention.
It was not well received.
What other thoughts do you have on protocols?
I was

I have to thank you for providing such a great collection of knowledge and evidence based practice regarding sepsis. Over the past few years I’ve seen sepsis management work really well, such as the Code SMART at Newark Beth Israel Medical Center http://www.hindawi.com/journals/ccrp/2012/980369/ and sepsis management that hasn’t quite gotten off the ground for reasons that I cannot explain nor quite understand. As an ED nurse I value the Severe Sepsis Triage Screening Tool that was part of the New York City Severe Sepsis Project you posted a while back. I feel it is an easy way to get the sepsis ball rolling, however when I presented it to our sepsis committee there was a lack of enthusiasm because the concern was that the symptoms could be applied to a young otherwise healthy person with strep throat who is not actually septic. Our current process is to draw the needed labs and give 2.5 L NS bolus, and additional fluid boluses to manage hypotension (yes I’m aware of the 30mL/kg bolus, but for some reason 2.5L is what the docs in my shop like). Now I understand the importance of fluid resuscitation, however without non invasive serial lactates or IVC US monitoring or invasive old school CVP or Scvo2 monitoring, how do we know when we have hit the fluid bolus wall, especially in CHF and ESRD patients. My ED does not practice CVP or IVC monitoring and serial lactates are not the norm. Shouldn’t there be some sort of follow up with the interventions that we are implementing? It seems simple to me, just like when you transfuse someone with a few units and recheck a cbc 6-8 hours later or trending troponin in chest pain patients.

Having listened to a lot of PI today and the lack of adequate boluses for sepsis patients I had inquired if pre hospital 500mL boluses counted, and I was told NO (medical direction comes from our ED– kind of like an order to bolus the patient one would think). I was wondering if other shops are counting prehospital fluid resuscitation? I mean when I gave solumedrol 125mg enroute for COPD we certainly counted it as a dose, so why not a bolus for sepsis?

Is there any concrete evidence regarding IVC US that I could throw my attending(s) way to maybe interest them in learning a new trick? I mean I would send them all to SMACC but I’m a nurse and I have a 13 year old who needs braces.

And lastly when your shop implemented the Severe Sepsis Project how did you get the nurses on board? Were they pissed that there was yet another paper to check off boxes on, or did they embrace it as a helpful tool?

While my philosophy is very much in line with your “Bring upstairs care downstairs” I am only able to advocate for baby steps. I think if I brought up albumin I might get kicked off the committee, but hey maybe next week!

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